International Medical Devices Database

Manufacturer Address
Mizuho USA, Inc., 12131 Community Rd, Poway CA 92064-8801
Source
USFDA
1 Event
- Recall of Device Recall Confirm Clearly Smart

One device in the database

Device Recall Confirm Clearly Smart

Model / Serial
Confirm Clearly Starter Kits UPC Code 3-02340-30136-7 and Confirm Clearly Refills Kit UPC Code 3-02340-30138-1 (all lots including: Confirm Clearly Starter Kits Lot numbers : LE612, LE613, LF601, LF606, LF612, LG604, LG609, LG616, LH601, LH607, LH610, LH615, LH621, LJ607, LK605 & LK611 Confirm Clearly Refills Kits Lot numbers : LE611, LF603, LF611, LG602, LG605, LG613, LG614, LH602, LH603, LH611, LH612, LH614, LH619, LJ606, LK602 & LK610 Special Pack Deal (6 Starter Kits & 6 Refill Kits) Lot number; LH608
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide-USA and Canada
Product Description
Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138) || Note: || (1) Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick || (2) Confirm Clearly Refills Kits: The refill consists of three disposable test sticks.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Mizuho USA, Inc.

One device in the database

Device Recall Confirm Clearly Smart